3D Systems Receives US FDA 510(k) Clearance for Custom Ankle Surgery Guides

3D Systems (DDD) said Wednesday that it has received the US Food and Drug Administration's 510(k) clearance for its 3D printed Patient-Matched Guides, developed in partnership with Smith+Nephew for use in ankle replacement surgeries.

510(k) clearance indicates that the FDA has determined the device to be safe and effective by comparing it to a legally marketed device already on the market, allowing it to be sold in the US, according to the FDA's website.

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